BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPJ OCCLUSION BALLOON CATHETER

    MDR report key: 6471217 · Received April 7, 2017

    Report

    Report Number
    1820334-2017-00626
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    March 9, 2017
    Report Date
    October 3, 2017
    Manufacturer
    COOK INC
    Product Code
    EZN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CODE: 510(K): K091767. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. .

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, TRENDS, AND VISUAL INSPECTION OF THE ACTUAL DEVICE WAS COMPLETED DURING THIS INVESTIGATION. A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED A HOLE IN THE CATHETER/BALLOON GLUE BOND FROM THE DISTAL TIP. THE HOLE HAS A BURNT/BLACKEN APPEARANCE. DUE TO THE DAMAGE TO THE RETURNED DEVICE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION RESULTS, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. MEASURES HAVE BEEN PREVIOUSLY TAKEN TO ADDRESS THIS ISSUE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING MINI-PERCUTANEOUS NEPHROLITHOTOMY (PNL) PROCEDURE ON RIGHT KIDNEY. IT WAS REPORTED THAT THE OPERATOR WAS ABLE TO BLOCK THE KIDNEY WITH HELP OF UPJ OCCLUSION BALLOON CATHETER AND THE SALINE SOLUTION. THE OPERATOR NOTICED THAT HE WAS NOT ABLE TO DEFLATE THE BALLOON CATHETER WHILE TRYING TO REPOSITION IT INSIDE THE PATIENT¿S BODY. THE OPERATOR REMOVED THE T-PIECE AT THE END OF THE CATHETER BUT IT DID NOT HELP. THE BALLOON CATHETER WAS LATER DESTROYED WITH THE LASER INSIDE THE KIDNEY AND REMOVED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254914 UPJ OCCLUSION BALLOON CATHETER EZN DILATOR, CATHETER, URETERAL EZN COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1